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Bilastine 0.4%
Bilastine 0.4% is a H1 receptor antagonist Small molecule drug developed by Faes Farma, S.A.. It is currently in Phase 2 development for Seasonal and perennial allergic rhinitis, Chronic idiopathic urticaria.
Bilastine is an antihistamine that works by blocking the action of histamine, a substance in the body that causes allergy symptoms.
Bilastine is an antihistamine that works by blocking the action of histamine, a substance in the body that causes allergy symptoms. Used for Seasonal and perennial allergic rhinitis, Chronic idiopathic urticaria.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Bilastine 0.4% |
|---|---|
| Sponsor | Faes Farma, S.A. |
| Drug class | H1 receptor antagonist |
| Target | H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Allergy |
| Phase | Phase 2 |
Mechanism of action
Bilastine selectively and competitively inhibits peripheral H1-receptors, which are involved in the mediation of allergic reactions. This results in the relief of symptoms associated with allergic conditions such as itching, sneezing, and runny nose.
Approved indications
- Seasonal and perennial allergic rhinitis
- Chronic idiopathic urticaria
Common side effects
- Dizziness
- Headache
- Fatigue
- Dry mouth
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bilastine 0.4% CI brief — competitive landscape report
- Bilastine 0.4% updates RSS · CI watch RSS
- Faes Farma, S.A. portfolio CI
Frequently asked questions about Bilastine 0.4%
What is Bilastine 0.4%?
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Related
- Drug class: All H1 receptor antagonist drugs
- Target: All drugs targeting H1 receptor
- Manufacturer: Faes Farma, S.A. — full pipeline
- Therapeutic area: All drugs in Allergy
- Indication: Drugs for Seasonal and perennial allergic rhinitis
- Indication: Drugs for Chronic idiopathic urticaria
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing